Oral Testimony to FDA’s Part 15 Public Hearings on the Promotion of FDA-Regulated Medical Products Using the

Internet & Social Media Tools*

November 13, 2009

Enabling Patient Engagement & Healthcare Innovation

Zen Chu, Founder Accelerated Medical Ventures

Zen @ acmedx.com Twitter #FDASM @accelmed

Thank you to Dr. Abrams and the panel for inviting me to speak. I am here to encourage FDA restraint in order to allow new innovations to take root. My name is Zen Chu and I’m the founder of Accelerated Medical Ventures. I bring 15 years of perspective in early stage medical & high tech innovation, as an entrepreneur, investor and adviser to a handful of medical innovation programs. I’m also caregiver & parent to one of my kids with a chronic disease, and many of my comments are informed by the radical lifestyle changes our entire family experienced after the diagnosis. In the interest of transparency, I’ve had no business with large manufacturers or ad agencies and have no conflicts, and I hope that I provide a very different perspective from most of the testimony from industry. Surgeon General C Everett Koop once said “Drugs don’t work in patients who don’t take them.” I’ll offer a corollary of my own: Patients who aren’t engaged don’t comply with therapies or report complications. All of us here must preserve an atmosphere of clear risk/benefit communication while enabling innovative services to better engage connected patients and caregivers in the rapidly evolving world of new media, which crosses geographic and legal boundaries. Evidence, efficacy and patient health must be paramount. But I would also stress that compliance, understanding of risks and adverse event reporting are linked to patient engagement, and social media will serve as important “sentinel” networks. Most of the presenters are asking for clarity in marketing rules, focused on messages that precede diagnosis and treatment. However, it is very important to distinguish those communications from messages after a physician

has prescribed a treatment. Some of the most important messaging to patients must be delivered after the prescription, to educate patients on adherence, lifestyle changes, and potential complications. This is also the place in the disease lifecycle where adverse events occur. Health professionals know the enormous challenge of medication adherence & persistency. It goes far beyond patients forgetting to take or refill their meds. In fact, forgetting only accounts for about ¼ of the compliance problem. Studies consistently show that over 50% of non-compliance arises because patients choose not to take the prescribed therapies, for one of three reasons: - They don’t believe or feel the benefits - They fear the side effects, even if they aren’t experiencing them - Or the therapy costs too much. It is a failure of engagement & understanding, and social media can play an important role in addressing these patient activation issues. Moreover, studies show that patients retain little of what is communicated from a physician, due to intimidating terminology and short interactions. Often the modern physician consult mirrors a Fair Balance statement – lots of jargon thrown at patients can’t understand or retain it. Doctors are a critical gatekeeper for diagnosis and therapy, but most cannot spend the time necessary to engage patients & personalize protocols in today’s environment. Doctors cannot scale, but technology solutions can scale to fill the gap. Technology Examples & Challenges Technology can solve this, but business models do not yet exist. Let me describe some of the challenges. I hold in my hand what may be one of the best tools to engage & activate patients –not a smartphone, this is a dumb cellphone used by 80% of patients. This is the phone that Grandma has, and will continue to use for years to come. Fair balance statements do not fit. Even though I know of technologies and companies creating solutions for long-form health messages on these phones, my point is that the traditional Fair Balance statements are not appropriate to the medium and would only get in the way of meaningful interaction. Over 40 studies have shown that Interventional Health Messaging works, and may of these studies used only short messaging on phones (SMS). Messages alone work across socioeconomic and demographic segments to remind, nudge & educate patients at the right time, place and context.

This is the clinical power of new media messages. These messages succeed because they create structured protocols, distilled into understandable brief communications, personalized to patient segments. Patients need balanced interactions appropriate to the medium, not 1-click to full prescribing information which they are not capable or interested in digesting. Phones and social media have great potential, but even with the existing rigorous clinical data, broad commercial services don’t yet exist. Why is that? Pretty basic: messages & protocols are not refined and the sponsors of experiments are frozen due to FDA regulations on direct to consumer advertising and what is considered advertising. Disease management programs sponsored by insurers and employers have been an investment failure and have not penetrated beyond the sickest 5% of patients. Insurers don’t have the money to spend on furthering experiments on “disease management light.” But experiments are exactly what are needed to drive evidence, on an indication by indication basis to link message, medium, response and efficacy. These are the skills of the people focused on these hearings. Advertising and messaging experts will be key to persuading with engaging programs and building the evolving toolset. Advertising and sponsorship dollars are critical enablers of this innovation. Neither patients, nor doctors, nor hospitals, nor insurers are willing to pay for early services, and free services have a cost to develop and prove. More blinded controlled studies are done on the internet in one hour than are completed by the entire medical industrial complex in a decade. FDA and clinical research need to leverage the people and techniques of interactive media to benefit public health. New media holds promise as sentinels for patient safety and reporting, not only for adverse events, but also counterfeit product, off-label prescribing, drug interactions and the much more prevalent known complications which also need post-market monitoring. But patients don’t care about any of this until the event is upon them. Effective patient messaging is the prerequisite to these other monitoring functions.

I am an engineer, so sourcing and architecting solutions for adverse events seems straightforward to me. Many of the solutions proposed this morning by previous speakers should be adopted. Bottom line: MedWatch should be retooled, simplified, and syndicated and embedded across websites. FDA Notices of Violations, the resulting reactions from pharma advertisers, and Google’s AdWords data demonstrates the unintended consequences which negatively impacted transparency and patient engagement. That’s OK! We cannot know what we do not track, and now FDA notices and Google have provided the experimental data. Now FDA must adjust accordingly and rapidly. We all realize what a tough job it is for FDA to balance all of this. For patients to benefit, we must all be good experimentalists to make decisions based on evidence. Recommendations So here are my five recommendations, but let me preface them with a quote by the great philosopher Jiddu Krishnamurti: “To observe clearly, one must be free to look.” 1) FDA restraint will enable more experimentation, rigorous data and innovation. I hope that DDMAC can lend enough clarity to allow that engagement while avoiding regulations that place artificial barriers between companies, healthcare institutions, physicians & patients. Barriers to new media engagement will only invite the fringe alternative and snake oil salesmen into the vacuum. Patient engagement and health will suffer. 2) DDMAC should provide guidelines to distinguish pre-script marketing from post-script education messaging to enable innovation of new services to engage patients. 3) Create a New Media & Technology Advisory Board, from experts in disease management, health messaging, innovation and clinical research. This will enable my last two recommendations. 4) FDA needs to build a team & strategy in order to be proactive, not just for adverse events. It’s clear even to me, observing this from a safe distance, that DDMAC needs to hire more people versed in interactive media and technology.

FDA’s current solutions provide anachronistic paper-based methods amid an environment of exponential data growth. Guidance must iterate more frequently and needs to be specific to each medium, and that takes people. Hire more people and charge fees for allowing experimental messaging campaigns. Plenty of the companies present have brands with marketing budgets over $100MM for single brands and will pay to generate data that demonstrates increased adherence and the increased revenues that result. A framework is needed for areas of alignment between FDA and industry, where these experiments promise to benefit patient health. 5) Lastly, once you have a team and strategy, FDA can proactively encourage specific messaging experiments. Social networks have already been shown they can be vectors for healthy decisions. FDA and industry must leverage these social vectors by experimenting and iterating. Most of us are in healthcare because we love the mission and science of healthcare. All of that converges at FDA. Thank you for holding these important public hearings.

Zen Chu Copyright © 2009

* Note: This is the prepared text of my testimony submitted to FDA. However I’m sure that I added and omitted points in my oral remarks, so this is not the transcript, but very close.